Implant system

ABSTRACT

A system and method for inserting an implant into soft tissue. The system may include an elongate arm having an implant at a first end of the elongate arm and an actuator at a second end of the elongate arm. The implants may be contained in a cartridge assembly. Methods of inserting an implant may be used during nasal septum reconstruction.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Provisional Patent ApplicationSer. No. 60/972,449, filed Sep. 14, 2007, and U.S. Provisional PatentApplication Ser. No. 61/047,289, filed Apr. 23, 2008, the entirecontents of each are expressly incorporated herein by reference.

FIELD OF THE INVENTION

The present disclosure relates generally to systems and methods forinserting implants into a patient's soft tissue. The present disclosurerelates more specifically to systems and methods for connecting internaltissues to aid in healing and for approximation of soft tissues duringhead and neck surgical procedures such as nasal septum reconstruction.

BACKGROUND INFORMATION

In certain medical procedures, it may be desirable to connect internaltissues to aid in healing. One example of such a procedure is nasalseptum reconstruction (also known as septoplasty). During a septoplasty,mucoperichondrial flaps are formed on each side of the septum and thedeviated cartilage and bone are removed. During the procedure, it isdesirable to approximate the flaps to reduce the deadspace and minimizethe likelihood of hematoma between the flaps, which may lead to seriouscomplications such as saddle nose deformity.

Existing techniques to approximate the flaps and reduce the deadspaceinclude packing the nasal cavity to bring the flaps into proximity,which can cause high levels of discomfort to the patient and may lead totoxic shock syndrome. More often, the flaps are sutured with a runningdegradable suture. Suturing in such a small space is very difficult,even for the most highly trained surgeon and can also have complicationssuch as trauma to the lateral wall of the nasal cavity and needlebreakage. The use of implants to approximate the flaps and reduce thedeadspace near the tissue can reduce patient discomfort and provide forapproximation of the soft tissue in specific locations.

SUMMARY

Exemplary embodiments of the present disclosure comprise an implantsystem comprising: a first elongate arm having a first end and a secondend; a cartridge assembly proximal to the first end, wherein thecartridge assembly comprises a plurality of implants; and a handleassembly proximal to the second end, wherein the handle assemblycomprises a handle and an actuator. In certain embodiments, the implantsystem is configured to discharge an implant from the cartridge assemblywhen the actuator is actuated. The actuator may comprise a trigger, andthe actuator may be configured to engage an actuator rod when theactuator is actuated. The actuator rod may be configured to discharge animplant when the actuator is actuated. Certain embodiments may comprisea biasing member configured to bias the actuator rod away from the firstend of the first elongate arm. In certain embodiments, the actuator rodmay be configured to move generally parallel to the first elongate armduring use, and the actuator rod may comprise a ram configured to engagethe actuator during use.

In certain embodiments, the actuator rod may comprise a flexible endproximal to the plurality of implants, and the flexible end of theactuator rod may be configured to engage an implant during use. Certainembodiments may comprise a guide that directs the flexible end of theactuator rod at an angle to the first elongate arm during use, and theguide may be proximal to the first end of the first elongate arm. Incertain embodiments, the cartridge assembly may be disposable.

Certain embodiments may comprise a second elongate arm comprising adistal end and a proximal end, and the second elongate arm may begenerally parallel to the first elongate arm when the actuator is notactuated. In certain embodiments, the implant system may be configuredto move the distal end of the second elongate arm closer to the firstend of the first elongate arm when the actuator is actuated. Certainembodiments may comprise a cam gear having a cam surface engaged withthe second elongate arm, wherein the actuator comprises an actuator gearengaged with the cam gear, and actuation of the actuator causes the camsurface to move the second elongate arm. Certain embodiments maycomprise an actuator having a cam surface engaged with the secondelongate arm, wherein actuation of the actuator causes the cam surfaceto move the second elongate arm. In certain embodiments, the pluralityof implants are comprised of an absorbable copolymer.

Certain embodiments of the present disclosure comprise an implant systemcomprising: an elongate arm having a first end and a second end; animplant proximal to the first end; and an actuator proximal to thesecond end, wherein the implant system is configured to discharge animplant at an angle to the elongate arm when the actuator is actuated.In certain embodiments, the angle may be between 0 and 180 degrees; morespecifically the angle may be between 0 and 90 degrees or morespecifically between 0 and 45 degrees. In specific embodiments, theangle may be approximately 90 degrees; in still other embodiments, theangle may be approximately 45 degrees. Certain embodiments may comprisean actuator rod between the actuator and the implant, wherein theactuator rod comprises a flexible end proximal to the implant.

Other embodiments of the present disclosure comprise a method forapproximation of soft tissues, the method comprising. The method maycomprise: providing an implant system comprising an elongate arm havinga first end and a second end; a cartridge assembly proximal to the firstend, wherein the cartridge assembly comprises a plurality of implants;and an actuator configured to discharge an implant from the cartridgeassembly. The method may also comprise inserting the elongate arm into apatient's nasal cavity and locating the first end proximal to a targetimplant location. The method may also comprise actuating the actuator;and discharging an implant into the target implant location.

Other embodiments of the present disclosure comprise an implant for usein approximating tissues, the implant comprising: a base portion; astem; and a head portion configured for capturing tissue during use. Incertain embodiments, the implant may comprise a base portion that isT-shaped or L-shaped. The head portion may be asymmetric and/or comprisea barb. In certain embodiments, the head portion comprises a pair ofextensions extending past the stem and a slot in each extension. Incertain embodiments, the implant is cannulated. The implant may comprisean aperture extending through the implant.

Certain embodiments of the present disclosure comprise an implant systemcomprising: a first elongate arm having a first end and a second end; animplant proximal to the first end; a handle assembly proximal to thesecond end, wherein the handle assembly comprises a handle and anactuator; a first actuator rod comprising a first flexible portionproximal to the first end, wherein the first flexible portion isconfigured to engage the implant; and a second actuator rod comprising asecond flexible portion proximal to the first end, wherein the secondflexible portion comprises a first tip configured to penetrate tissue

In certain embodiments, upon partial actuation of the actuator: theactuator is operatively engaged with the first and second actuator rods;the first flexible portion of the first actuator rod is engaged with theimplant; and the second actuator rod is configured such that the firsttip extends past the implant.

In certain embodiments, upon full actuation of the actuator: theactuator is operatively engaged with the first and second actuator rods;the implant is discharged from the implant system; and the secondactuator rod is configured such that the first tip extends past theimplant. In certain embodiments, the implant comprises a bevel proximalto the a distal end of the implant. In specific embodiments, the beveldirects the implant toward the second flexible portion when the implantis penetrating into tissue during use.

In certain embodiments, the implant comprises an aperture and the secondflexible portion is configured to extend through the aperture upon fullactuation of the actuator. In specific embodiments, the implantcomprises a slot and the second flexible portion is configured to extendthrough the slot upon full actuation of the actuator. In certainembodiments, the second flexible portion comprises a second tip. Thesecond tip may be configured to extend through an aperture or slot inthe implant.

Certain embodiments comprise a system configured to discharge theimplant at an angle to the first elongate arm. In specific embodiments,the implant is part of a cartridge assembly when the actuator isactuated. Certain embodiments may further comprise a second elongate armcomprising a distal end and a proximal end. In specific embodiments, thesecond elongate arm is generally parallel to the first elongate arm whenthe actuator is not actuated.

The term “coupled” is defined as connected, although not necessarilydirectly, and not necessarily mechanically.

The use of the word “a” or “an” when used in conjunction with the term“comprising” in the claims and/or the specification may mean “one,” butit is also consistent with the meaning of “one or more” or “at leastone.” The term “about” means, in general, the stated value plus or minus5%. The use of the term “or” in the claims is used to mean “and/or”unless explicitly indicated to refer to alternatives only or thealternative are mutually exclusive, although the disclosure supports adefinition that refers to only alternatives and “and/or.”

The terms “comprise” (and any form of comprise, such as “comprises” and“comprising”), “have” (and any form of have, such as “has” and“having”), “include” (and any form of include, such as “includes” and“including”) and “contain” (and any form of contain, such as “contains”and “containing”) are open-ended linking verbs. As a result, a method ordevice that “comprises,” “has,” “includes” or “contains” one or moresteps or elements, possesses those one or more steps or elements, but isnot limited to possessing only those one or more elements. Likewise, astep of a method or an element of a device that “comprises,” “has,”“includes” or “contains” one or more features, possesses those one ormore features, but is not limited to possessing only those one or morefeatures. Furthermore, a device or structure that is configured in acertain way is configured in at least that way, but may also beconfigured in ways that are not listed.

Other objects, features and advantages of the present invention willbecome apparent from the following detailed description. It should beunderstood, however, that the detailed description and the specificexamples, while indicating specific embodiments of the invention, aregiven by way of illustration only, since various changes andmodifications within the spirit and scope of the invention will beapparent to those skilled in the art from this detailed description.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a perspective view of an exemplary embodiment of animplant system.

FIG. 2 illustrates a perspective view of the exemplary embodiment ofFIG. 1.

FIG. 3 illustrates an exploded view of the exemplary embodiment of FIG.1.

FIG. 4 illustrates a partial section side view of the exemplaryembodiment of FIG. 1.

FIG. 5 illustrates a partial section side view of the exemplaryembodiment of FIG. 1.

FIG. 6 illustrates a partial side view of the exemplary embodiment ofFIG. 1.

FIG. 7 illustrates a partial side view of the exemplary embodiment ofFIG. 1.

FIG. 8 illustrates a partial side view of the exemplary embodiment ofFIG. 1.

FIG. 9 illustrates a partial exploded view of the exemplary embodimentof FIG. 1.

FIG. 10 illustrates a partial section view of the exemplary embodimentof FIG. 1.

FIG. 11 illustrates a partial section view of the exemplary embodimentof FIG. 1.

FIG. 12 illustrates a perspective view of a component of the exemplaryembodiment of FIG. 1.

FIG. 13 illustrates a perspective view of a component of the exemplaryembodiment of FIG. 1.

FIGS. 14-25 illustrate perspective and orthogonal views of a componentof the exemplary embodiment of FIG. 1.

FIGS. 26-27 illustrate the exemplary embodiment of FIG. 1 during use.

FIGS. 28-29 illustrate orthogonal views of a first exemplary embodimentof an implant and installation component.

FIGS. 30-32 illustrate orthogonal views of a second exemplary embodimentof an implant and installation component.

FIGS. 33-34 illustrate orthogonal and perspective views of a thirdexemplary embodiment of an implant and installation component.

FIGS. 35-36 illustrate perspective views of a fourth exemplaryembodiment of an implant.

FIGS. 37-39 illustrate orthogonal and perspective views of a fifthexemplary embodiment of an implant and installation component.

FIGS. 40-41 illustrate perspective and orthogonal views of a sixthexemplary embodiment of an implant.

FIGS. 42A-46 illustrate orthogonal and perspective views of a fifthexemplary embodiment of an implant and installation component.

FIGS. 47-51 illustrate sectional views of a portion of an implantsystem.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

Referring now to the exemplary embodiment shown in FIGS. 1 through 12,an implant system 100 comprises a handle assembly 130 and a cartridgeassembly 160 that can be coupled to or separated from handle assembly130. Handle assembly 130 comprises a right casing 132 and a left casing134, a counter tension arm 136, a cam gear 138, a handle 131, and anactuator 140. In the embodiment shown, actuator 140 comprises a trigger141 and an actuator arm 146. In other embodiments, actuator 140 maycomprise different configurations, such as including a cam surface, alever, switch, or other actuating mechanism. In the exemplary embodimentshown, actuator 140 also comprises a pivot point 145 and a gear 148,Handle assembly 130 further comprises a plurality of screws 142 and pins144 to couple right casing 132 to left casing 134. Right casing 132 andleft casing 134 can be coupled with glue, ultrasonic welding or othercommonly practiced methods. Cartridge assembly 160 comprises a housing162 and a cartridge arm 164. A cartridge lock 147 can be positioned toretain cartridge assembly 160 to handle assembly 130 or to releasecartridge assembly 160 from handle assembly 130.

As shown in the views of FIGS. 4-8, cartridge assembly 160 comprises anactuator rod 165 with a ram 163. As actuator 140 is actuated (i.e.pulled toward handle 131), actuator 140 pivots around pivot point 145,and gear 148 engages cam gear 138. In addition, actuator arm 146 movestoward ram 163. As shown in FIG. 7, when actuator 140 is pulled asufficient amount, actuator arm 146 engages ram 163 and moves actuatorrod 165 within cartridge arm 164 of cartridge assembly 160.

In the exemplary embodiment shown in FIGS. 4-8, cam gear 138 has aneccentric cam surface 139 that engages counter tension arm 136.Eccentric cam surface 139 has an effective diameter that is variable fora portion of cam surface 139 and constant for a portion of cam surface139. In this exemplary embodiment, the effective diameter is thedistance from the center of cam gear 138 to the portion of cam surface139 engaging counter tension arm 136. As cam gear 138 rotates (whileactuator 140 is being pulled), cam surface 139 initially causes countertension arm 136 to move towards cartridge arm 164. At a certain point inthe actuation of actuator 140 (just past the location shown in FIG. 7),the effective diameter of cam surface 139 reaches a maximum value. Asthe actuation of actuator 140 is continued, counter tension arm 136 ismoved to the position shown in FIG. 8. In this manner, counter tensionarm 136 moves toward cartridge arm 164, and can provide backing supportfor tissue located between counter tension arm and cartridge arm 164.

In addition to the movement of counter tension arm 136, the actuation ofactuator 140 also causes actuator arm 146 to move towards ram 163. Asexplained above, when actuator arm 146 reaches the position shown inFIG. 7, it engages ram 163 and causes actuator rod 165 to slide withincartridge assembly 160. As shown in FIGS. 9 and 10, cartridge assembly160 comprises housing 162, cartridge arm 164, ram 163, actuator rod 165,a cartridge 166 holding a plurality of implants 167, a guide 168, asupport member 161 and a biasing member 169. Actuator rod 165 comprisesa distal end 173 that engages guide 168 during operation. Biasing member169 exerts a force against ram 163 and biases ram 163 and actuator rod165 towards the proximal end of cartridge assembly 160 (i.e. the enddistal from guide 168). As previously described, actuator 140 can beactuated so that actuator arm 146 contacts ram 163. Continued actuationof actuator 140 can cause actuator arm 146 to overcome the force exertedby biasing member 169, so that ram 163 and actuator rod 165 are movedtowards guide 168.

In the exemplary embodiment shown, guide 168 comprises a curved surface178 that receives distal end 173 as actuator rod 165 is actuated duringoperation. As actuator rod 165 moves toward guide 168, distal end 173engages curved surface 178 and is directed towards an implant 167.Distal end 173 can thereby displace an implant 167 from cartridge 166(as shown in FIG. 11). During use, cartridge 166 can be located proximalto a tissue (not shown) into which implant 167 will be implanted. Distalend 173 can exert a sufficient force on implant 167 to cause implant 167to penetrate the tissue. Though the guide 168 is shown to translate thedistal end 173 ninety degrees, it should be noted that this translationcan be any direction between 0° and 180°. In the exemplary embodimentshown, implant 167 is therefore ejected or discharged at an angle ofapproximately ninety degrees to cartridge arm 164. In other embodiments,implant 167 may be discharged at an angle to cartridge arm 164 that isgreater than or less than ninety degrees. In one exemplary embodiment,implant 167 may be discharged at an angle to cartridge arm 164 that isapproximately 45 degrees.

Referring now to the exemplary embodiment of FIG. 12, a perspective viewof the underneath side of cartridge assembly 160 shows one orientationof housing 162, cartridge arm 164, actuator rod 165, cartridge 166,implants 167 and guide 168. In the exemplary embodiment shown, distalend 173 is narrower than the remaining portions of actuator rod 165 andenters cartridge 166. In other exemplary embodiments, distal end 173 mayhave a different configuration than that shown in FIG. 12. For exampledistal end 173 may not be narrower than the remaining portions ofactuator rod 165. Implants 167 extend from cartridge 166 in a manner sothat distal end 173 can discharge the implant 167 that is proximal toguide 168. In certain embodiments, a biasing member 186 biases implants167 towards guide 168. When one implant 167 is discharged, distal end173 is retracted back into the cartridge assembly 160, and the remainingimplants 167 move towards guide 168. A subsequent actuation of actuator140 will then discharge an additional implant 167.

As shown in FIG. 13, distal end 173 may comprise any of severaldifferent configurations. For example, distal end 173 may be a ribbon orstrip of constant width as shown in end 173A, or distal end 173 maycomprise a varying width as shown in end 173B. Distal end 173 may alsocomprise a varying thickness as shown in an end 173C. Distal end 173 mayalso have a cut-out (or cut-outs) as shown in 173D or tabs as shown in173E. Distal end 173 may be made of any suitable material. Examples ofsuch materials comprise plastic and/or metal, including superelasticmaterials such as nickel titanium, commonly referred to as Nitinol®. Itis understood by one skilled in the art that other embodiments of distalend 173 may comprise combinations of the features disclosed, oradditional features.

Referring now to FIGS. 14-25, various exemplary embodiments of implantsare illustrated. As shown in FIGS. 14-16, implant 167A comprises a post121, a transverse section 122, a barb 123, and a pointed tip 124.Pointed tip 124 reduces the amount of force needed to insert implant167A into tissue (not shown), and barb 123 assists in holding implant167A in the desired location. Transverse section 122 holds the tissue inplace and also reduces the likelihood that implant 167A will beaccidentally pushed through the tissue into which it is inserted.Implant 167B shown in FIG. 17 is similar to implant 167A, but comprisesa tip 125 with a straight edge rather than a point. Implant 167C is alsosimilar, but comprises a tip 126 with a single beveled point rather thanthe multiple bevel point shown in FIG. 14. Implant 167D shown in FIG. 19comprises a barb 127 that is perpendicular to the primary axis (notshown) of the implant. Implant 167E of FIG. 20 comprises multipletransverse sections 128, while implant 167F shown in FIG. 21 alsocomprises multiple barbs 129. FIG. 22 shows implant 167G with a roundcross-section instead of the rectangular or square cross-section shownin previous embodiments. FIG. 23 shows an implant with an ellipticalbarb 111. FIG. 24 illustrates an implant 167I with a disc-shapedtransverse member 112, while FIG. 25 illustrates an implant 167J with arib 113 rather than a transverse member.

In certain embodiments implant 167 may be approximately four to sixmillimeters long, two to three millimeters wide, and approximately 0.4to 0.7 millimeters thick. More specifically, implant 167 may be 4.5 to5.5 millimeters long, 2.3 to 2.7 millimeters wide, and 0.5 to 0.6millimeters thick. In a specific exemplary embodiment, implant 167 isapproximately 5 millimeters long, 2.5 millimeters wide, and 0.55millimeters thick. In certain exemplary embodiments, implant 167comprises an absorbable copolymer comprising approximately 60 to 80percent polyactide and approximately 20 to 40 percent polyglycolide.More specifically, implant 167 may comprise an absorbable copolymercomprising approximately 65 to 75 percent polyactide and approximately25 to 35 percent polyglycolide. In a specific exemplary embodiment,implant 67 comprises an absorbable copolymer comprising approximately 70percent polyactide and approximately 30 percent polyglycolide. In stillother specific embodiments, implant 67 comprises an absorbable copolymercomprising approximately 90 percent polyactide and approximately 10percent polyglycolide. In other embodiments, implants 167 may benon-absorbable.

Referring now to FIGS. 26 and 27, implant system 100 is shown in anexemplary method of use during a nasal septum reconstruction. As shownin FIG. 26, implant system 100 is positioned proximal to a patient'snose 200. In this embodiment, implant system 100 is positioned so thatcartridge arm 164 is proximal to a nasal cavity 210 and counter tensionarm 136 is proximal to a nasal cavity 220.

Referring now to FIG. 27, implant system 100 is then positioned so thatcartridge arm 164 is inserted into nasal cavity 210 and counter tensionarm 136 is inserted into nasal cavity 220. Implant system 100 isinserted the desired amount so that the distal ends of cartridge arm 164and counter tension arm 136 are located proximal to a target locationwhere it is desired to place an implant 167 into a mucoperichondrialflap formed in the patient's septum (not visible in FIGS. 26 and 27).When implant system 100 is positioned at the desired location, anoperator stabilizes implant system 100 and actuates (i.e. pulls back on)actuator 140. As described in the discussion of the preceding figures,the actuation of actuator 140 causes counter tension arm 136 to movetowards cartridge arm 164. Counter tension arm 136 can therefore providebacking support to the tissue into which the implant 167 will beinserted. The actuation of actuator 140 also causes distal end 173 ofactuator rod 165 to force an implant 167 from cartridge 166.

In the embodiment shown in FIGS. 26 and 27, counter tension arm 136supports tissue on one side of the patient's septum, while an implant167 is inserted into a mucoperichondrial flap on the opposite side ofthe patient's septum. In certain exemplary embodiments, initial implants167 are placed anteriorly and superiorly within nasal cavity 210 ascompared to subsequent implants 167. In certain embodiments, implants167 are placed within approximately two centimeters of each other. Inother embodiments, implants 167 are placed within approximately 1.5centimeters of each other, and in still other embodiments, implants 167are placed within approximately one centimeter of each other.

In certain embodiments, implants 167 may be placed in both nasalcavities 210 and 220, while in other embodiments implants 167 may beplaced in either nasal cavity 210 or nasal cavity 220. After theoperator has placed implants in the bilayered mucosal flaps, theoperator may visualize both nasal cavity 210 and 220 to assure adequateapproximation and sufficient penetration of all staples through theflaps. After the tissue is appropriately approximated and all flaps aresecured, the operator may dispose of cartridge 166 and any remainingimplants 167. However, the remaining components of implant system 100may be sterilized reused for future procedures.

Referring now to FIGS. 28 and 29, front and side views are shown of oneembodiment of an implant 1. Implant 1 can be configured for use inconjunction with previously-described embodiments. As shown, a baseportion of implant 1 is engaged with a ribbon 2. In certain embodiments,ribbon 2 is equivalent to distal end 173 of actuator rod 165 of theembodiment described in FIGS. 1-12. In this embodiment, implant 1comprises a T-shaped portion 3 which can act as a support against atissue surface (not shown) when implant 1 is installed. In theembodiment shown, stem 6 couples T-shaped portion 3 to a barb 55 whichhas a point 4 created by the intersection of two faces 5 and 7. Inexemplary embodiments, faces 5 and 7 do not need to be symmetrical or ofthe same length. As shown, the included angle 56 between faces 5 and 7is slightly modified (as compared, for example, to embodiments shown inFIGS. 16 and 19) by configuring face 7 so that it is angled toward acenter axis (not shown) of stem 6. By angling face 7 towards face 5, theintersection of faces 5 and 7 at point 4 is closer to the center axis ofstem 6, which can provide for more stable tissue piercing during use.Certain embodiments may also comprise a face 12 as shown in FIG. 29 tofurther assist in piercing tissue during use. As shown in FIG. 28, acapture surface 8 provides an area that can assist in keeping the backside of pierced tissue in approximation with T-shaped portion 3. In theembodiment shown, capture surface 8 is extends from only on one side ofthe stem 6, but in other embodiments, it could also extend beyond bothsides of stem 6.

During use, the embodiment shown in FIGS. 28 and 29 can be installedsimilar to other previously-described embodiments. For example, ribbon 2can be pushed in the direction shown arrow 11. Ribbon 2 comprises a topportion 9 that can be pushed against the a bottom portion 10 of implant1. The action of ribbon 2 against bottom portion 10 of implant 1 canassist pushing point 4 and barb 55 of implant 1 through the desiredtissue(s). The tissue can then be captured between the T-shaped portion3 and the capture surface 8. Implant 1 and ribbon 2, as with otherembodiments presented in this document, can be made of metal or plastic,and in particular embodiments, biodegradable plastic. The ribbon 2, aswith other embodiments presented in this document, can be made of metalor plastic and superelastic materials such as nickel titanium, commonlyreferred to as Nitinol®.

FIGS. 30-32 present an embodiment which comprises a second (or guide)ribbon 15 configured to create an initial hole in the tissue (not shown)and to give implant 1 stability during deployment. This system consistsof the implant 1 being pushed from its bottom by a first ribbon 13.Second ribbon 15 has been placed against the first ribbon 13 and implant1.

The two ribbons 13 and 15 can be seen more clearly in FIG. 31. The firstribbon 13 has a top surface 19 for pushing against the implant. Thesecond ribbon 15 has a narrowed section or extension 21 with a point atthe tip 20.

The action of this design can be best seen in FIG. 32. The first ribbon13 pushes against the implant 1 at the base of T-shaped portion 18. Inthis exemplary embodiment, the tapered end or point 20 of the secondribbon 15 is shown above the implant tip 4 in order to create a leadinghole in the tissue for easier deployment. In other embodiments, point 20can be even with the implant tip 4 or slightly below. With extension 21in place, the implant 1 is restricted from moving in that directionduring installation. During installation, a tissue that implant 1 isbeing inserted through will exert reactionary forces on chamfer 12 asimplant 1 passes through the tissue. These forces will to help directimplant 1 in a direction indicated by arrow 17 as implant 1 is pushedthrough the tissue. Such a configuration can create a more stabledeployment of implant 1 by effectively holding implant 1 in placeagainst extension 21.

Another exemplary embodiment is shown in FIGS. 33 and 34. In thisembodiment, however, implant 24 is hollow or cannulated and a ribbon 28is placed in an aperture 27 extending through implant 24. In theembodiment shown, ribbon 28 has a leading point 23 and implant 24 has aT-shaped portion 26 and a tissue-capturing head 25. Extra bevels 29 canbe added if desired to improve staple insertion through tissue. Inalternate embodiments, a second ribbon can be used to push on a baseportion of implant 24 during installation.

Yet another exemplary embodiment of a cannulated implant 30 is shown inFIGS. 35 and 36. In this embodiment, implant 30 comprises a stem, a headportion 31 with a chamfer 37, and a base with a T-shaped portion 32. Theconfiguration of this embodiment can provide for a more simplifiedmanufacturing process. For example, if implant 30 is made via aninjection molding process, core pins of a mold (not shown) may be usedcreate the cavities 34, 35, and 38 which can be coupled to create onepassage 33. Passage 33 can be configured to accept a narrowed portion orextension of a ribbon, similar to aperture 27 in previously-describedembodiments. A chamfer 36 may also be included to assist a ribbonextension in properly loading into the channel 33 in case the alignmentis off slightly.

Another exemplary embodiment is shown in FIGS. 37, 38 and 39. In thisembodiment, implant 40 comprises a stem, a head portion 44 and a basewith a T-shaped portion 43. Instead of a single extension being placedin the middle of implant 40, two extensions 41 are used on either sideof the center axis of implant 40. Extensions 41 may have leading points42 and extend from a top portion 45 of a single ribbon 39. Theembodiment shown may also provide simplify manufacturing processes (if,for example, implant 40 is manufactured by injection molding ormachining) since the slots 46 and 47 are open to the sides.

Still another exemplary embodiment is shown in FIGS. 40 and 41. In thisembodiment, implant 48 comprises a stem 49, a head portion 51 and a basewith a T-shaped portion 50. In the embodiment shown, head portion 51comprises a pair of barbs 54 and an asymmetric point 53 that is closerto one barb 54 (i.e. the left barb 54 as shown in FIG. 41) than theother barb 54. The barb 54 that is closer to asymmetric point 53 alsocomprises a slot 52 that can accommodate a ribbon with a point (notshown) during deployment. In certain embodiments, asymmetric point 53which can allow head portion 51 to blend with the ribbon more easilyduring deployment.

FIGS. 42A-46 present an embodiment which comprises a first (or push)ribbon 311 and a second (or guide) ribbon 310. Second ribbon 310 isconfigured to create an initial hole in the tissue (not shown) and togive an implant 301 stability during deployment. In FIG. 42 implant 301comprises a stem or shaft 303 with a barb 302 on one side and a T-shapedsection or crossbar 304 on the other side. This embodiment comprises atapered end or point 305 proximal to barb 302. Point 305 can be used tohelp guide the implant 301 through tissue. Barb 302 comprises a capturesurface or overhang 306 and a barb recess or trough 309. In thisembodiment, crossbar 304 comprises two capture surfaces or faces 307 anda crossbar recess or trough 308. During installation and use, point 305goes through the tissue until it emerges from the other side. The tissueis then held between the overhang 306 and the faces 307 with the aid ofthe shaft 303.

In the top view of the staple in FIG. 43, barb trough 309 and thecrossbar trough 308 are more evident. The same is true for FIG. 44,which is the bottom view of implant 301.

In FIGS. 45 and 46 implant 301 is shown in approximation to first ribbon311 and second ribbon 310 as is the case when deploying implant 301.Second ribbon 310 has a narrowed section or extension 312 on the distalend with a tapered end or point 313 that initial pierces the tissuecreating a leading hole for implant 301 to more easily pass through thetissue. First ribbon 311 has a flat edge 314 on the distal end thatpushes against a lower surface 317 of the crossbar 304 in order to pushthe staple through the tissue.

Implant 301 is stabilized during the deployment phase in part by thefirst ribbon 311 and second ribbon 310. Extension 312 of first ribbon310 engages crossbar trough 308 to keep the implant 301 from moving sideto side (e.g. towards or away from the plane of the paper in FIG. 46).Extension 312 also fits into or engages barb trough 309 to restrictmovement in one direction. Implant 301 is also constrained from rotatingin one direction 315 by the rigidity of the implant 312, whereas implant312 is constrained in the opposite direction 316 by a channel in theimplant system (not shown in FIGS. 45-46, but shown as channel 57 inFIG. 47). First ribbon 311 comprises an engagement surface 314 thatengages lower surface 317 during installation. In this embodiment,engagement surface 314 is a flat edge at one end of first ribbon 311.The engagement of these engagement surface 314 and lower surface 317also tends to keep implant 301 in a stable, straight position duringinstallation.

A more detailed set of drawings describing the deployment method ofexemplary embodiments is shown in FIGS. 47 to 51. In FIG. 47 the systemat rest consists of a channel 57 enclosing a curved first ribbon 59(shown in solid black heavier line weight) and a curved second ribbon58. In certain embodiments, first ribbon 59 is similar to distal end 173of actuator rod 165 in the embodiment described in FIGS. 1-12. Inaddition to the components described in FIGS. 1-12, the system shown inFIGS. 47-51 comprises second ribbon 58, which can further assist inplacing an implant into a desired tissue location, as described in moredetail below.

Also shown in the Figures are several implants 60 lined up ready fordeployment. In the embodiments shown, channel 57 is resting against alayer of tissue 61. In FIG. 48, an actuator (not shown) has beenpartially actuated and ribbons 58 and 59 are beginning to deploy suchthat the distal end 62 of first ribbon 59 is in contact with a firstimplant 60. As shown in FIG. 49, when actuation of the actuatorcontinues, the ribbons 58 and 59 are further deployed, with secondribbon 58 creating a hole in the tissue 61 and the first ribbon 59beginning to push implant 60 through that hole. In FIG. 50, the actuatorhas been fully actuated and first and second ribbons 58 and 59 are fullydeployed. Implant 60 is now in its installed position with the baseportion and head portion on opposite sides of tissue 61. Although notvisible in the cross-section views of FIGS. 47-51, implant 60 maycomprise a T-shaped base portion on one side of tissue 61 and a barb ortissue-capturing head section on the opposite side of tissue 61 (whenimplant 60 is in its final installed location). As shown in FIG. 51,first and second ribbons 59 and 58 have been retracted to their originalposition in FIG. 51 leaving the implant 60 within the tissue 61. Implant60 may comprise any of the disclosed embodiments (as well as variationsthereof).

While exemplary embodiments are described herein, it will be understoodthat various modifications to the method and apparatus can be madewithout departing from the scope of the present invention. For example,different configurations of implants may be used. In specificembodiments, an implant may have an L-shaped portion rather than aT-shaped portion near its base. Furthermore, certain embodiments may notcomprise implants in a cartridge arrangement. In addition, the implantsmay be used in procedures other than septoplasty. For example, any areawhere tissue approximation is necessary in an enclosed space such asperitoneal, urethral, bladder, GI tract, esophageal repair, or jointrepair. Furthermore, the sequential recitation of steps in any claim isnot a requirement that the steps be performed in any particular order,unless otherwise so stated.

The invention claimed is:
 1. An implant system comprising: a handleassembly comprising a handle and an actuator, a first elongate armhaving a first end and a second end coupled to the handle assembly; asecond elongate arm having a first end and a second end coupled to thehandle assembly, the second elongate arm being movable between an openposition substantially parallel to the first elongate arm and a closedposition wherein the first end of the second elongate arm is closer tothe first end of the first elongate; arm a cartridge assembly coupled toand proximal to the first end of the first elongate arm, wherein thecartridge assembly comprises a plurality of implants; wherein theactuator is configured to engage an actuator rod when the actuator isactuated and wherein the actuator rod comprises a flexible end proximalto the plurality of implants.
 2. The implant system of claim 1, whereinthe implant system is configured to discharge an implant from thecartridge assembly towards the second elongate arm when the actuator isactuated.
 3. The implant system of claim 1, wherein: the actuatorcomprises a trigger; and the actuator rod is configured to discharge animplant when the actuator is actuated.
 4. The implant system of claim 3,further comprising a biasing member configured to bias the actuator rodaway from the first end of the first elongate arm.
 5. The implant systemof claim 3 wherein a portion of the actuator rod is configured to movegenerally parallel to the first elongate arm during use.
 6. The implantsystem of claim 3 wherein the actuator rod comprises a ram configured toengage the actuator during use.
 7. The implant system of claim 1 whereinthe flexible end of the actuator rod is configured to engage an implantduring use.
 8. The implant system of claim 7, further comprising a guidethat directs the flexible end of the actuator rod at an angle to thefirst elongate arm during use.
 9. The implant system of claim 6, whereinthe guide is proximal to the first end of the first elongate arm. 10.The implant system of claim 1, wherein the cartridge assembly isdisposable.
 11. The implant system of claim 1 wherein the implant systemis configured to move the second elongate arm to the closed positionwhen the actuator is actuated.
 12. The implant system of claim 1,further comprising a cam gear having a cam surface engaged with thesecond elongate arm, wherein: the actuator comprises an actuator gearengaged with the cam gear; and actuation of the actuator causes the camsurface to move the second elongate arm.
 13. The implant system of claim1, further comprising an actuator having a cam surface engaged with thesecond elongate arm, wherein: actuation of the actuator causes the camsurface to move the second elongate arm.
 14. The implant system of claim1 wherein the plurality of implants are comprised of an absorbablecopolymer.
 15. An implant system comprising: a handle; a first elongatearm having a proximal end coupled to the handle and a distal end, thedistal end being configured to receive an implant; a second elongate armhaving a proximal end coupled to the handle and a distal end, the secondelongate arm being movable between an open position substantiallyparallel to the first elongate arm and a closed position wherein thedistal end of the second elongate arm is closer to the distal end of thefirst elongate arm; an actuator coupled to the handle proximal to theproximal end of the first elongate arm, wherein the implant system isconfigured to move the second elongate arm between the first and secondpositions and discharge an implant from the distal end of the firstelongate arm toward the second elongate arm at an angle to the firstelongate arm when the actuator is actuated; and an actuator rod betweenthe actuator and the implant, wherein the actuator rod comprises aflexible end proximal to the implant.
 16. The implant system of claim15, wherein the angle is between 0 and 180 degrees.
 17. The implantsystem of claim 15 wherein the angle is between 0 and 90 degrees. 18.The implant system of claim 15, wherein the angle is approximately 90degrees.
 19. The implant system of claim 15, wherein the angle isapproximately 45 degrees.
 20. A method for approximation of softtissues, the method comprising: providing an implant system comprising:an elongate arm having a first end and a second end; a cartridgeassembly proximal to the first end, wherein the cartridge assemblycomprises a plurality of implants; an actuator configured to dischargean implant from the cartridge assembly; and an actuator rod between theactuator and the plurality of implants, wherein the actuator rodcomprises a flexible end proximal to the implant; inserting the elongatearm into a patient's nasal cavity; locating the first end proximal to atarget implant location; actuating the actuator; and discharging animplant into the target implant location.
 21. An implant systemcomprising: a first elongate arm having a first end and a second end; animplant proximal to the first end; a handle assembly proximal to thesecond end, wherein the handle assembly comprises a handle and anactuator; a first actuator rod comprising a first flexible portionproximal to the first end, wherein the first flexible portion isconfigured to engage the implant; and a second actuator rod comprising asecond flexible portion proximal to the first end, wherein the secondflexible portion comprises a first tip configured to penetrate tissue.22. The implant system of claim 21 wherein upon partial actuation of theactuator: the actuator is operatively engaged with the first and secondactuator rods; the first flexible portion of the first actuator rod isengaged with the implant; and the second actuator rod is configured suchthat the first tip extends past the implant.
 23. The implant system ofclaim 22 wherein upon full actuation of the actuator: the actuator isoperatively engaged with the first and second actuator rods; the implantis discharged from the implant system; and the second actuator rod isconfigured such that the first tip extends past the implant.
 24. Theimplant system of claim 21 wherein the implant comprises a bevelproximal to the a distal end of the implant.
 25. The implant system ofclaim 24 wherein the bevel directs the implant toward the secondflexible portion when the implant is penetrating into tissue during use.26. The implant system of claim 21 wherein the implant comprises anaperture and the second flexible portion is configured to extend throughthe aperture upon full actuation of the actuator.
 27. The implant systemof claim 21 wherein the implant comprises a slot and the second flexibleportion is configured to extend through the slot upon full actuation ofthe actuator.
 28. The implant system of claim 21 wherein the secondflexible portion comprises a second tip.
 29. The implant system of claim28 wherein the second tip is configured to extend through an aperture orslot in the implant.
 30. The implant system of claim 21 wherein thesystem is configured to discharge the implant at an angle to the firstelongate arm.
 31. The implant system of claim 21 wherein the implant ispart of a cartridge assembly when the actuator is actuated.
 32. Theimplant system of claim 21, further comprising a second elongate armcomprising a distal end and a proximal end.
 33. The implant system ofclaim 32, wherein the second elongate arm is generally parallel to thefirst elongate arm when the actuator is not actuated.